Renal ImpairmentPhase 1NCT02647918
Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function
A Phase 1 study testing Sotagliflozin in people with Renal Impairment and Healthy, run by Lexicon Pharmaceuticals at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment, Healthy
- What is being tested?
- Sotagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2015to Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male and female subjects ≥18 to ≤75 years of age
- Body mass index ≥18.0 to ≤36.0 kg/m2, at Screening
- Subjects with mild, moderate, or severe renal impairment, or ESRD requiring HD
- Control group of matched healthy subjects
- Willing and able to provide written informed consent
Who cannot join
- Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results
- Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin
- History of any major surgery within 6 months
- History of hepatic disease, or significantly abnormal liver function test
- Women who are breastfeeding or are planning to become pregnant during the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lexicon Investigational Site
Miami, Florida, 33014
Lexicon Investigational Site
Minneapolis, Minnesota, 55404
Lexicon Investigational Site
Orlando, Florida, 32809
Lexicon Investigational Site
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 1, Open-label, Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function
The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.
- Conditions
- Renal Impairment, Healthy
- Being tested
- Sotagliflozin
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotagliflozinDrug
Single dose
SotagliflozinDrug
2 single doses
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects with normal renal function Receives: Drug: Sotagliflozin |
| Group 2 | Experimental | Subjects with mild renal impairment Receives: Drug: Sotagliflozin |
| Group 3 | Experimental | Subjects with moderate renal impairment Receives: Drug: Sotagliflozin |
| Group 4 | Experimental | Subjects with severe renal impairment Receives: Drug: Sotagliflozin |
| Group 5 | Experimental | Subjects with ESRD requiring HD Receives: Drug: Sotagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events
Measured: Day 1 to Day 8
Secondary outcomes (1)
Plasma concentration of sotaglifozin to evaluate AUC
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suman Wason, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647918
- Sponsor's protocol ID
- LX4211.1-121-REN
- Other IDs
- LX4211.121
- Status last verified
- Feb 2019
- First submitted
- 30 Dec 2015
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT02647918
- Acronym / sponsor ID
- LX4211.1-121-REN
- Conditions
- Renal Impairment, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: SotagliflozinSubjects with normal renal function |
| Group 2 | Experimental | Drug: SotagliflozinSubjects with mild renal impairment |
| Group 3 | Experimental | Drug: SotagliflozinSubjects with moderate renal impairment |
| Group 4 | Experimental | Drug: SotagliflozinSubjects with severe renal impairment |
| Group 5 | Experimental | Drug: SotagliflozinSubjects with ESRD requiring HD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male and female subjects ≥18 to ≤75 years of age
- Body mass index ≥18.0 to ≤36.0 kg/m2, at Screening
- Subjects with mild, moderate, or severe renal impairment, or ESRD requiring HD
- Control group of matched healthy subjects
- Willing and able to provide written informed consent
Key exclusion criteria (5 listed)
- Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results
- Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin
- History of any major surgery within 6 months
- History of hepatic disease, or significantly abnormal liver function test
- Women who are breastfeeding or are planning to become pregnant during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotagliflozinSingle dose | Drug | Group 1, Group 2, Group 3, Group 4 |
| Sotagliflozin2 single doses | Drug | Group 5 |
Primary outcome
Number of treatment emergent adverse events
Time frame: Day 1 to Day 8
1 secondary outcome
Plasma concentration of sotaglifozin to evaluate AUC
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Wason, MD study director
Lexicon Pharmaceuticals, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sotagliflozin in people with Renal Impairment and Healthy, run by Lexicon Pharmaceuticals at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment emergent adverse events (time frame: Day 1 to Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.